4CIS SARA Spine System, 4CIS VERTU Spine System

Thoracolumbosacral Pedicle Screw System

Solco Biomedical Company India Private Limited

The following data is part of a premarket notification filed by Solco Biomedical Company India Private Limited with the FDA for 4cis Sara Spine System, 4cis Vertu Spine System.

Pre-market Notification Details

Device IDK202498
510k NumberK202498
Device Name:4CIS SARA Spine System, 4CIS VERTU Spine System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Solco Biomedical Company India Private Limited Survey No.1540, Beside Torrent Pharma, Ahmedabad Village-rajpur,  IN 382715
ContactViral Sheth
CorrespondentDarshak Shah
Solco Biomedical Company India Private Limited Survey No.1540, Beside Torrent Pharma, Village-Raj Ahmedabad Mehsana Highway, Ta-Kadi, Dist-Mehsana Ahmedabad,  IN 382715
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-31
Decision Date2021-02-18

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